FDA.reportPublic FDA data

Sparkle

Primary DI
10850036179044
Brand
Sparkle
Company
Sparkle Innovations Inc.
Model
Applicator Super Plus
Device description
Organic Cotton Cardboard Applicator Tampons, Super Plus, 14u
Published
2022-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850036179044PackageGS112In Commercial Distribution
00850036179047PrimaryGS10
00850036179085Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003617904410850036179044
00850036179047008500361790478500361790470850036179047
00850036179085008500361790858500361790850850036179085

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118331371
Device count
14
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850036179023SparkleApplicator, Regular2022-07-05
00850036179030SparkleApplicator Super2022-07-05
00850036179047SparkleApplicator Super Plus2022-07-05
00850036179054SparkleNon-applicator, Regular2022-07-05
00850036179061SparkleNon-applicator, Super2022-07-05
00850036179078SparkleNon-applicator, Super Plus2022-07-05
10850036179020SparkleApplicator, Regular2022-07-05
10850036179037SparkleApplicator Super2022-07-05
10850036179051SparkleNon-applicator, Regular2022-07-05
10850036179068SparkleNon-applicator, Super2022-07-05
10850036179075SparkleNon-applicator, Super Plus2022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
10198926000307BIOPURE Quest USA Corp.HEB2025-03-01
10198926000314BIOPURE Quest USA Corp.HEB2025-03-01
10198926000338BIOPURE Quest USA Corp.HEB2025-03-01
10198926000352BIOPURE Quest USA Corp.HEB2025-03-01
09336798002249MoxieThe trustee for Millie & More Unit TrustHEB2025-02-06
00030772162217TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2024-08-07
00032251911798Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911804Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911842Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911859Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911866Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911873Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911880Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911897Family WellnessFamily Dollar StoresHEB2024-07-08
09421904034037OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034044OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034051OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034433OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034440OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034457OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034495OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034501OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034921OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
10075289065009Comfort PlusTRANZONIC COMPANIES, THEHEB2023-06-12
10075289064965Comfort PlusTRANZONIC COMPANIES, THEHEB2022-12-30
10075289064941Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14
10075289064958Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14
10075289064972Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14